e u r o p e a n f e r t i l i z e r m a n u f a c t u r e r s a s s o c i a t i o n

2 008

GUIDANCE FOR THE PREPARATION OF SAFETY DATASHEETS FOR FERTILIZER MATERIALS

Version

Issue date

1 Identification of the substance/preparation and of the company/undertaking

2

3

CAS no. EC no. % (w/w)

CAS no. EC no. % (w/w)

4

Conforms to 1907/2006/EC

Safety Data Sheet

Hazardous ingredients

Other ingredients

Chemical name

Chemical name

EU index number (Annex 1)

Use of the substance/preparation

Company e-mail for SDS

Emergency telephone

First aid measures

Composition/information on ingredients

Hazards identification

Skin contact

Environmental hazards

Health hazards

Classification

Physical and chemical hazards

Note to physician

Eye contact

Other

General

Ingestion

Inhalation

EC no. means EINECS or ELINCS number.

Classification

Synonyms

Chemical formula

CAS No.

EC No

Company name

Company address

Company telephone

Product name

Commercial product name

Common chemical name

REACH or National Product Registration No.

Firm logo

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GUIDANCE FOR THEPREPARATION OF

SAFETY DATA SHEETSFOR FERTILIZER MATERIALS

Copyright 2008 EFMA

EFMAEuropean Fertilizer Manufacturers’

Association

Avenue E. van Nieuwenhuyse, 6

B-1160 Brussels

Belgium

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CONTENTS

1. INTRODUCTION 3

2. SCOPE 3

3. RELEVANT LEGISLATION 4

3.1 EU based 4

3.2 International Transport 5

3.3 National 5

3.4 REACH Regulation 6

3.5 Classification 7

3.5.1 Current system of classification 7

3.5.2 GHS and its EU adaptation 7

4. HOW TO USE THIS GUIDANCE 8

5. INDIVIDUAL SECTIONS OF SAFETY DATA SHEETS 9

5.1 General 9

5.2 Sections of Safety Data Sheets 9

6. REFERENCES 23

7. ABBREVIATIONS 25

APPENDICES

APPENDIX 1 Provisional List of substances and preparations of modelSafety Data Sheets 28

APPENDIX 2 Model EFMA Safety Data Sheet Format 29

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DisclaimerThe information and guidance in this Booklet is given in good faith. The EuropeanFertilizer Manufacturers’ Association (EFMA), its consultants, its member companiesand their staff accept no liability for any incident, loss, damage or any otherconsequences arising from the use, misuse, practical application of or reliance on theinformation given in this document.

Users of this Booklet are advised to consult the relevant latest legislation, as changes inthe regulations may have been made since its publication.

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1. INTRODUCTIONIn 1996 EFMA produced a guidance booklet on the preparation of Safety Data Sheets(SDSs) (Ref. 1) for the benefit of its members. Its purpose was to help the members ofEFMA in the preparation of their own SDSs by describing the requirements of varioussections in the relevant EC Directives, 67/548/EEC (Ref. 2) (see note below) and1999/45/EC for preparations (Ref. 3), and by providing agreed versions of model SafetyData Sheets for several fertilizer materials. It was recognised that some of the materialscovered were not legally required to have a SDS but they were included on the principleof good responsible care.

The above-mentioned Directives have been superseded by new, far-reachinglegislation, Regulation (EC) No 1907/2006, widely known as REACH (Registration,Evaluation, Authorisation and Restriction of Chemicals (Ref. 4). This Regulation nowdefines SDS requirements and also introduces new requirements. It has, therefore,become necessary to revise the 1996 EFMA guidance with a view to facilitatingcompliance with the current REACH legislation. An EFMA Task Force, set up for thispurpose, has produced this new guidance. The previous guidance contained modelSDSs for fertilizer materials; these are now given in a separate document (to be releasedlater). The provisional list of substances and preparations thus to be covered is given inAppendix 1.

Note: The most recent and relevant consolidated version of Directive 67/548 isDirective 92/32/EC.

2. SCOPEThis guidance describes the requirements of REACH concerning the provision of SDSs,as practised in 2008.

It seeks to cover most of the requirements of sections 1 to 16 as defined in Annex IIof Regulation (EC) 1907/2006 (REACH), which can be addressed at this stage. Under91/155/EEC SDSs are required for substances placed on the market, manufactured orimported in quantities in excess of 10 tonnes/year and meeting the criteria forclassification as dangerous. Under REACH they assume a more significant role thanthat required under 91/155/EEC.

REACH states that a chemical safety assessment (CSA) shall be performed and achemical safety report (CSR) completed for all substances subject to registration inaccordance with Article 14. A CSR records the results and conclusions of the CSA. ACSA may also be performed for preparations. The CSA process, according to Article14, shall focus on the following steps:

a) human health hazard assessment;

b) physicochemical hazard assessment;

c) environmental hazard assessment;

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d) persistent, bioaccumulative and toxic (PBT) and very persistent and verybioaccumulative (vPvB) assessment.

Annex I (General Provisions for assessing substances and preparing chemical safetyreports) of the REACH Regulation offers some immediate guidance as to what isrequired. In addition, more detailed guidance is provided by the European ChemicalsAgency (Ref. 5).

In the case of substances or preparations classified as dangerous, Exposure Scenariosand risk characterisation must also be included in the CSRs according to their specifiedand registered uses. The relevant Derived No Effect Level (DNEL) and Predicted NoEffect Concentration (PNEC) for the substance or preparation will have to be derivedand given for the Exposure Scenarios set out in the annex to the SDS. This guidancecannot at this stage cover these elements. When the full CSRs are prepared, thisguidance will be revised accordingly.

3. RELEVANT LEGISLATION Examples of the main ones are given below.

3.1 EU based• REACH: Regulation (EC) No 1907/2006 of the European Parliament and of the

Council of 18 December 2006 concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH). More details are givenbelow in 3.4.

• Chemical classification (CPL Directive): Council Directive 67/548/EEC of 27June 1967 on the approximation of laws, regulations and administrativeprovisions relating to the classification, packaging and labelling of dangeroussubstances (as amended), and Directive 1999/45/EC of the European Parliamentand the Council of 31 May 1999 concerning the approximation of the laws,regulations and administrative provisions of the Member States relating to theclassification, packaging and labelling of dangerous preparations (as amended).

• Waste Directive.

• Regional transport legislation.

• SEVESO Directive: Directive 2003/105/EC of the European Parliament and ofthe Council of 16 December 2003 Amending Council Directive 96/82/EC on thecontrol of major-accident hazards involving dangerous substances. OJ L345, 31-12-2003, p 97.

• Dangerous Substances (re exposure limits).

• Regulation EC2003/2003 of the European Parliament and of the Council of 13October 2003 relating to fertilizers. OJ L304, 21-11-2003, p 1.

• Restriction on marketing.

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3.2 International Transport • ADR: European Agreement concerning the International Carriage of Dangerous

Goods by Road, Vols. I & II, ISBN 92-1-139112-1.

• RID: Convention concerning International Carriage by Rail (COTIF). AppendixB. Uniform Rules concerning the Contract for International Carriage of Goods byRail (CIM). Annex I Regulations concerning the International Carriage ofDangerous Goods by Rail (RID). 2005 Edition.

• ADN: European Agreement concerning the International Carriage of DangerousGoods by Inland Waterways (ADN). ECE/TRANS/190 – Complete set of twovolumes Sales # E.06.VIII.2 – ISBN 92-1-139118-0 (Vol. I & II).

• IMDG: International Maritime Dangerous Goods (IMDG) Code 2008 Edition.Two volumes. IMO Publications, IG200E. ISBN 978-92-801-4241-9.

• BC Code: Code of Safe Practice for Solid Bulk Cargo, 2004, IMO publicationID260E, ISBN 13: 978-92-801-4201-3.

• IATA DGR: International Air Transport Association, Dangerous Goods Manual.

3.3 National For example:

Germany:

• Die Verwaltungsvorschrift wassergefährdende Stoffe (VwVwS) vom 17. Mai1999 und Die geänderte Fassung der VwVwS vom 27. Juli 2005 (AdministrativeRegulation on the Classification of Substances hazardous to waters into WaterHazard Classes).

• Die Technischen Regeln für Gefahrstoffe (TRGS). Ammoniumnitrat, TRGS 511,Juni 2004, (Technical rules for dangerous materials).

UK:

• Ammonium Nitrate Materials (High Nitrogen Content) Safety Regulations 2003,SI 1082/2003.

Spain:

• Royal Decree 2016/2004, 11th of October, approval of Complementary TechnicalInstruction MIE APQ-08 “Storage of ammonium nitrate fertilizer with a highnitrogen content”.

• Royal Decree 888/2006, 21st of July, approval of Rules and Regulations for thestorage of fertilizers based on ammonium nitrate, with a nitrogen content equal toor lower than 28% by mass.

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France:

• SEVESO: Decret n°2005-989 du 10 aout 2005 modifiant la nomenclature desinstallations classées. Storage code for AN-based fertilizer is 1331 with 3 possibleclasses: 1331-I (SSD), 1331-II (Detonability) & 1331-III (not dangerous). Fornon-conforming materials the classification is 1332.

Netherlands:

• Opslag van vaste minerale anorganische meststoffen, (PGS7: Storage of solidmineral inorganic fertilizers).

3.4 REACH RegulationThis Regulation considers the provision of a SDS as the key element in the hazard andrisk management communication from chemical substance suppliers and formulators toDownstream Users (DU).

The legal requirements as described below, are based on the current REACHlegislation and may need further adaptation to comply with the Globally HarmonizedSystem for the Classification and Labelling of Dangerous Chemicals (GHS) after itsimplementation.

The REACH Regulation stipulates, in article 31, the following requirementsconcerning the provision of SDSs:

• Where a substance or preparation meets the criteria for classification as dangerousin accordance with Directives 67/548/EEC or 1999/45/EC, the supplier of asubstance or a preparation shall provide the recipient of the substance orpreparation with a SDS compiled in accordance with Annex II of the REACHRegulation.

• Where a preparation does not meet the criteria for classification as dangerous inaccordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains in anindividual concentration of ≥ 1% by weight for non-gaseous preparations and≥ 0.2 % by volume for gaseous preparations at least one substance posing healthor environmental hazards, or one substance for which there are Communityworkplace exposure limits, the supplier shall provide the recipient at his requestwith a SDS compiled in accordance with Annex II of the REACH Regulation.

• The SDS shall be supplied in an official language of the Member State(s) wherethe substance or preparation is placed on the market, unless the Member State(s)concerned provide otherwise.

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3.5 Classification

3.5.1 Current system of classification

The current system/regulation for Classification and Labelling in the EU involves anevaluation of the hazard of a substance or preparation in accordance with Directives67/548/EEC (substances) and 1999/45/EC (preparations) and a communication of thathazard via the label. This evaluation must be made for any substance or preparationmanufactured within or imported into the EU and placed on the EU market. This mayresult in the classification of the substance/preparation as dangerous for one or severalend-points concerning physical-chemical properties, health or environmental effects.

The three relevant key legislative instruments are:

• Dangerous Substances Directive (67/548/EEC);

• Dangerous Preparations Directive (1999/45/EC);

• REACH Regulation (EC) No 1907/2006.

3.5.2 GHS and its EU adaptation

The goal of the United Nations Globally Harmonized System (GHS, Ref. 6) is toidentify the intrinsic hazards found in chemical substances and mixtures and to conveyinformation about these hazards. The criteria for hazard classification are harmonised.Hazard statements, symbols and signal words have also been standardised andharmonised; these now form an integrated hazard communication system. The GHSprovides a common approach for harmonised classification and hazard communicationfor different target audiences, such as consumers, workers, emergency responders andthose involved in transport. Therefore, it includes a “building block” approach to enablecountries to adopt the system having regard to the various target audiences in differentlegal areas.

The GHS uses the term “hazard classification” to indicate that only the intrinsichazardous properties of substances or mixtures (preparations) are considered.

The adoption of the UN GHS into EU legislation has taken place in three steps: On27th of June 2007, the European Commission adopted the “Proposal for a Regulationof the European Parliament and of the Council on Classification, Labelling andPackaging of Substances and Mixtures, and amending Directive 67/548/EEC andRegulation (EC) No 1907/2006” (COM(2007) 355 final, (Ref. 7). Its purpose was toalign the EU system of classification, labelling and packaging of substances andmixtures to the GHS. The proposed Regulation also takes over provisions of theREACH Regulation regarding the notification of classifications, the establishment of alist of harmonised classifications and the creation of a classification and labellinginventory. On 3 September 2008 a large majority of the European Parliament supporteda “compromise package” for a new Regulation to align existing EU legislation to the

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GHS. Finally on 1 December 2008 agreement was reached by the Member States forthe adoption and implementation of the above Regulation.

The new Classification, Labelling and Packaging (CLP) Regulation replaces theterm ‘preparation’ with ‘mixture’ and the term ‘dangerous’ with ‘hazardous’.

The number of classified substances resulting from the application of the new systemis estimated to be approximately the same as under the current system. However, dueto changes in cut-off values and calculation methods, more preparations – now calledmixtures – will probably be classified under the new system. The application of the newcriteria will result in a different classification compared to the current one for somesubstances and mixtures.

Time Lines:

As a Regulation, GHS will become immediately enforceable as law in all MemberStates simultaneously 20 days after its publication at EU level.

After entry into force, the deadline for substance reclassification is proposed to be 1December 2010 and for mixtures 1 June 2015. There will be a transitional periodwhereby the existing classification rules will still be applicable for substances andmixtures for a certain period of time after the introduction of the new law. EU transportlegislation will incorporate relevant GHS criteria by 2007 and 2009, in line with thetimetable for the adoption of the UNECE Model Regulation.

4. HOW TO USE THIS GUIDANCEThis guidance document attempts to describe and explain the sixteen sections, whichare mandatory for inclusion in SDSs. It outlines what needs to be included in thesesections, based on the information given in REACH, Annex II.

Companies would produce SDSs displaying their letterhead particulars on the frontpage if they were to adopt the full guidance and use the templates given here. Ifcompanies choose to write their own SDS it is hoped that the contents will be fairlyidentical; however, they will be free to use the model SDS as a basis with minorchanges as deemed necessary e.g. for different countries the national regulations wouldbe different, differences arising from different company policies or different test resultsfor their specific products. EFMA is trying to avoid significantly different messagesgoing out to customers for similar products with respect to health, safety andprecautions.

In the guidance text, in order to distinguish between sections in the main body of theguidance from the sections which form part of the SDSs, the former are given asnumbers only e.g. 3.4 and the latter as section followed by number e.g. section 7.

The link between the model EFMA SDS format given in Appendix 2 and the detailedtext in this guidance is provided by means of:

i) The use of the same section numbers and titles

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ii) Underlining (in the guidance text) of items and phrases within the sectionswhich require responses in the right hand columns or require consideration inthe model SDS e.g. CAS Number.

5. INDIVIDUAL SECTIONS OF SAFETY DATA SHEETS

5.1 GeneralA SDS should be compiled in accordance with REACH, Annex II, which specifiessixteen sections and their intended contents. These are explained below in 5.2. Eachsection should be completed as fully as possible with the relevant information and data.Where no information can be given, the item could be omitted or addressed by anappropriate comment such as

• not applicable e.g. flammability of ammonium sulphate and loose bulk density ofliquid ammonia

• not available where the required data or information is not available.

A blank SDS in the form of an excel sheet has been prepared to facilitate EFMAmembers to give the relevant information for their products in the preparation of theirSDS; this is given in Appendix 2.

There are a number of EFMA guidance documents, which can provide usefulinformation for completing the SDS and are also suitable for listing in section 16 of theSDS. The main ones are given in References 8-17. Further useful information can alsobe accessed from EFMA’s web site and the Product Stewardship manual.

Give the following information at the top or at the end to clarify the status of theSDS:

• Date of previous issue

• Date of revision

5.2 Sections of Safety Data Sheets

Section 1: Identification of the substance/preparation and of the company/undertaking

Provide identification by way of a term identical to that on the label as set out in AnnexVI to Directive 67/548/EEC e.g. commercial product name.

Common Chemical Name

Synonyms

Chemical formula

EU index number: See Directive 67/548/EEC (Annex 1).

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EC Number means EINECS or ELINCS number and is applicable for substancesonly, not for preparations.

CAS Number: Chemical Abstracts Service registration number

If applicable, specify the relevant registration number e.g. according to REACH ornational scheme. It is permitted to use other means of identification if available.

Use of the substance/preparation:

Indicate its use as far as is known. Where there are many possible uses only the mostimportant need to be listed.

Examples of use descriptions would be:

• Use as solid fertilizers.

• Use in the production of liquid fertilizers.

• Industrial or technical uses e.g. production of N2O, cooling mixtures, chemicalintermediates.

• Non-fertilizer products do not have a designated name. For fertilizer products thedesignated name given in the EU Fertilizer Regulation 2003/2003 can be used.

Company/undertaking identification:

• Give the name, address and telephone number of the Company (the “person”responsible for placing the substance or preparation on the market within the EU,whether it is the manufacturer, importer or distributor).

Company e-mail for SDS:

• Give the e-mail address where issues concerning the SDS can be addressed.

Emergency telephone:

• Give the emergency telephone number of the Company and/or relevant officialadvisory body. Specify the time period this phone number is available e.g. 24hours, 08:00-17:00.

Section 2: Hazards identification

Classification:

Give the classification of the substance or preparation which arises from theapplication of the classification rules in Directives 67/548/EEC or 1999/45/EC. If theproduct is not classified this should be stated e.g. not classified as hazardous materialaccording to Directives 67/548/EEC or 1999/45/EC.

Physical and chemical hazards:

Indicate clearly and briefly the main physical and chemical hazards.

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Health hazards and Environmental hazards:

• Describe the most important adverse human health (skin, eye, ingestion andinhalation routes) and environmental effects and symptoms relating to the usesand possible misuses that can reasonably be foreseen.

• If necessary, mention other hazards, such as dustiness, suffocation, freezing orenvironmental effects such as hazards to soil-dwelling organisms, etc., which donot result in classification but which may contribute to the overall hazards of thematerial.

Other:

If necessary, indicate here any other hazards not covered above.

Section 3: Composition/information on ingredients

Give information to enable the recipient to identify readily the hazards of thecomponents of the preparation.

Hazardous ingredients

Indicate the classified dangerous/hazardous substances present in the preparationwith

• Chemical name,

• Identification number (EINECS/ELINCS as per Directive 67/548/EEC or CAS),

• Concentration range in the preparation and

• Classification (symbol, letters and R phrases numbers, as per Articles 4 and 6 ofDirective 67/548/EEC or from Annex I to Directive 67/548/EEC).

For a preparation classified as dangerous, indicate the following substances (nameand the registration number, if available), together with their concentration orconcentration range:

• Substances presenting a health or environmental hazard, if present inconcentrations ≥ the lowest of the applicable concentrations (see Directive67/548/EEC and Directive 1999/45/EC), and

• Substances (not already included) for which there are Community workplaceexposure limits.

For a preparation not classified as dangerous, indicate the following substances(name and the registration number, if available), if they are present in an individualconcentration of ≥ 1% by weight for non-gaseous preparations and ≥ 0.2% by volumefor gaseous preparations:

• Substances (not already included) for which there are Community workplaceexposure limits.

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Other ingredients

A general description of the components and their concentrations can be helpful butit is not necessary to give the full composition (nature of the ingredients and theirconcentration).

If the identity of certain substances is to be kept confidential, describe their chemicalnature in order to ensure safe handling, using the same name as that which is derivedfrom the above procedures (ref: Article 15 of Directive 1999/45/EC or the footnote topoint 3.3 of the REACH Annex II).

Section 4: First-aid measures

Describe the first-aid measures.

• General: Specify first whether immediate medical attention is required oradvisable. Where applicable, specify the provision of special facilities at theworkplace for specific and immediate treatment.

• Subdivide the information according to the different routes of exposure, i.e.Inhalation, Ingestion, Skin contact and Eye contact, under different subheadings.Include guidance on the necessary first-aid measures if given in any related Riskand Safety phrases.

• The information on first-aid shall be brief and easy to understand by the victim,bystanders and first-aid personnel, covering the symptoms and effects in brief;actions to take on the spot in the case of an accident and whether delayed effectscan be expected after exposure.

• Include any specific Note to physician, where appropriate.

Section 5: Fire-fighting measures

Refer to the requirements for fighting a fire caused by the substance or preparation, orarising in its vicinity by indicating:

• Suitable extinguishing media: Suitable extinguishing media relevant to the scaleof the fire.

• Extinguishing media not be used for safety reasons.

• Specific hazards arising from the substance or preparation itself under fireconditions.

• Hazardous thermal decomposition and combustion products and/or resultinggases, e.g. NOx from AN-based fertilisers.

• Special fire fighting procedures (if known) for fire-fighters. Include specialwarnings that may be triggered from Risk phrases e.g. R14 Reacts violently withwater.

• Special protective equipment for fire-fighters: Include any special protectiveequipment (if known).

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Section 6: Accidental release measures

Cover as appropriate:

• Personal precautions, such as:

– Removal of ignition sources, provision for sufficient ventilation.

– Respiratory protection, control of dust, prevention of skin and eye contact.

• Environmental precautions, such as:

– Keeping away from drains, surface- and ground-water and soil, possible needto alert the neighbourhood.

• Methods for cleaning up:

i) In the event of spilled or leaked material, consider both large (e.g. from trucksand large storage facilities) and small (e.g. from 25 kg bags, small tanks etc)spills.

ii) Suggest suitable clean-up methods such as:

– Use of absorbent material (e.g. sand, diatomaceous earth, acid binder,universal binder etc.), reduction of gases/fumes with water, dilution.

– Consider the need for indications such as: “never use, neutralise with, e.g.do not use saw dust in the case of a spillage of AN.”

• Remarks

Include any additional information not covered above.

Section 7: Handling and storage

Information in this section shall relate to the protection of health, safety and theenvironment. It should assist the employer/user in devising suitable working proceduresand organisational measures according to Article 5 of Directive 98/24/EC.

Handling

• Specify precautions for safe handling e.g. avoid dust formation, avoidcontamination of AN fertilizers with combustible materials, avoidance ofpumping liquid products against a dead-end and provision of high temperatureprotection.

• Give advice on technical measures e.g.

– To contain and ventilate (local and general) to prevent aerosol/dust generationand fire.

– To protect the environment e.g. filters or scrubbers on exhaust gases, provisionof a bunded area, measures for collection and disposal of spillages, etc.

• Specify requirements or rules relating to the substance or preparation (e.g.procedures or equipment which are prohibited or recommended) and, whereappropriate, give a brief description.

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• Specify any special requirements to prevent fire and explosion e.g. cleanthoroughly any equipment handling AN-based fertilizers before undertaking hotwork.

Storage

• Specify the conditions for safe storage such as: specific design for storage roomsor vessels (including retention walls and ventilation), incompatible materials,conditions of storage (temperature limits, provision of inert gas, detectors etc.),special electrical equipment and prevention of static electricity.

• Give advice, if relevant, on any limits on the quantity of the material which canbe stored.

• Make reference to any national or local regulations concerning storage (e.g. PGS7in the Netherlands and TRGS511 in Germany)

• Include storage precautions as arising from the S-phrases, handling andpackaging.

• Advice on measures to preserve quality can be included here e.g. avoid exposureto direct sunlight.

For example, for storage of solid AN-based fertilizers:

• Locate away from the sources of heat or fire.

• Keep away from combustible and other incompatible materials.

• Ensure a high standard of housekeeping in the storage area.

• Any building used for the storage should be dry and well ventilated.

Specific use(s)

• Specify (detailed and operational) precautions for the safe handling of endproducts designed for specific use(s), referring to approved industry/sectorguidance e.g. various precautions to take when injecting liquid ammonia into soilas a fertilizer.

• For more complex advice, for example, on engineering approaches preferablyrefer to external sources of information.

Packaging materials

• Indicate any special requirements such as the type of material to be used (or whichmust not be used) in the packaging/containers of the substance or preparation.

• Packaging requirements should guarantee that no accidental release might occurduring transport. Reference could be made to the UN specification.

Section 8: Exposure controls/personal protection

Specify currently applicable specific control parameters including occupationalexposure limit values and/or biological limit values as applicable for the Member Statewhere the substance or preparation is placed on the market.

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This information should be taken into account by the employer in carrying out anassessment of the risk to the health and safety of workers for the substance orpreparation under Article 4 of Directive 98/24/EC, which requires the design ofappropriate work processes, engineering measures and hygienic measures.

Exposure control means the full range of specific protection and preventionmeasures to be taken during use in order to minimise worker and environmentalexposure. Note that exposure controls are related to S-phrases, triggered by thecorresponding R-phrases. Exposure to dust should be considered and the appropriateexposure values should be included in the SDS.

Each ingredient listed in section 3 that has an occupational exposure value specifiedshould be addressed.

Give particulars of the personal protection equipment (PPE) needed, informationshould complement that already given under section 7 (Handling).

Exposure limit values

• In the EU give those values used by regulatory bodies e.g.:

– European OEL (binding or indicative) established on the basis of the EuropeanScientific Committee for Occupational Exposure Limits (SCOEL).

– The national OEL committees of the European Member States.

• Additional information from non EU authoritative bodies can be included asappropriate:

– American Conference on Governmental Industrial Hygienists (ACGIH),setting so-called Threshold Limit Values (TLVs).

– American Industrial Hygiene Association, setting Workplace EnvironmentalExposure Limits (WEELs).

Engineering measures

If not already addressed in section 7, describe the use of adequate equipment andmaterials, the application of collective protection measures at source, e.g. adequateventilation to avoid excessive dust.

Hygienic measures

Where appropriate, indicate any additional skin protection measures and specifichygiene measures. Example for a standard sentence: “When handling the product do noteat, drink or smoke. Wash hands after handling and before eating, smoking and usingthe lavatory and at the end of the working period.”

Personal protection

Where needed, specify in detail which equipment will provide adequate and suitableprotection. Take into account Council Directive 89/686/EEC and amendments (Ref.18). Make reference to the appropriate CEN standards.

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• Respiratory system

For dangerous gases, vapours or dust, specify the type of protective equipment tobe used, such as self-contained breathing apparatus, masks and filters.

• Skin and body

State if it is necessary to protect a part of the body other than the hands and, if so,the type and quality of PPE required, e.g. apron, overall, boots, helmet and fullprotective suit.

• Hands

Specify the type of gloves to use, including the type of material, the breakthroughtime of the glove material with regard to the amount and duration of dermalexposure and, if necessary, indicate any additional hand protection measures.

• Eyes

Specify the type of eye protection e.g. safety glasses, safety goggles, face shield.

Environmental exposure controls

Further information such as environmental exposure controls may be required inrelation to the chemical safety report.

Section 9: Physical and chemical properties

• Provide all relevant information on the substance or preparation particularly theinformation listed below under “important health, safety and environmentalinformation”.

• Preferably the data should be given using SI units.

• Methods for the determination of physico-chemical properties are given in theCouncil Regulation EC No.440/2008 (Part A). (Ref. 19) and the UN Test Manual(Ref. 20).

General information

• Appearance. Indicate the physical state (solids, liquid, gas) and the colour of thesubstance or preparation e.g. white solid prills or granules, clear liquid

• Odour (if perceptible, give a brief description of it e.g. ammonia has a pungentodour)

Important health, safety and environmental information

• pH: Indicate the pH of the substance or preparation as supplied, or of an aqueoussolution; in the latter case, indicate the concentration

• Boiling point or range

• Melting point or range

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• Flash point

• Flammability

Where appropriate, give the lower and upper flammable/explosive limits. E.g.ammonia limits:

• Explosive properties (intrinsic properties of the product or its dust)

Detonation resistance

• Auto-ignition temperature

• Decomposition temperature e.g. decomposition of urea, AN.

• Minimum ignition energy

• Oxidising properties e.g. according to UN transportation classification 0.1 testmethod

• Critical temperature (for gases)

• Relative density (mostly given for gases and relative to air)

• Density

Material density: Mass per unit volume of the material included within the surfaceof the particles [EN 12944-2, EN 1236 & EN 1237] (Refs. 19, 21 and 22).

• Loose bulk density

Mass per unit volume of a material after it has been tipped freely into a containerunder clearly specified conditions [EN 12944-2, EN 1236].

Bulk density is expressed and measured in a number of different ways. Othermain types are given below:

– Bulk density (tapped): Mass per unit volume of a material tipped into a container and compactedunder clearly specified conditions [EN 12944-2, EN 1237].

– Packing (also called loading) density:Mass per unit volume of a material packed into a tube that is tappedintermittently causing compaction of the material in the tube. e.g. in the EUresistance to detonation test (Regulation EC 2003/2003).

• Vapour pressure at 20°C

• Vapour density

• Evaporation rate (relevant for ammonia and ammonia solution)

• Partition coefficient (n-octanol/water)

• Viscosity: kinematic or dynamic at specified temperature

• Mean particle size: d50

• Water solubility

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Other information

If of relevance, indicate other important safety parameters, such as, miscibility, fatsolubility, conductivity and gas group.

• Miscibility

• Fat solubility

• Conductivity

• Gas group: Of the fertilizer materials of interest, this item is relevant probablyonly for ammonia (Gas Group IIA). The gas/vapour group is used to determinethe type of electrical explosion proof equipment to select in an ATEX designatedatmosphere. (ATEX stands for Explosive Atmosphere). The ATEX Directives aremandatory. There are two EU ATEX Directives, one concerning equipment andprotective systems for use in potentially explosive atmospheres (94/9/EC) and oneconcerning the safety and health of workers potentially at risk from exposureto explosive atmospheres (99/92/EC). The International ElectrotechnicalCommission (IEC) publishes safety standards governing the use of electrical andelectronic equipment in gaseous atmospheres.

(The ability of an explosion flame to be propagated through a defined gap isdetermined in a standard apparatus. On the basis of the maximum permitted gapand minimum igniting current (current leading to ignition in a standardapparatus), gases and vapours are divided into three groups (II A, II B, II C; II Cbeing the group with the smallest maximum permitted gap)

• Remarks: Include any special attributes.

Section 10: Stability and reactivity

Stability

• It should be stated in this section that all fertilizer materials are stable under normalconditions of handling, storage and use (as recommended by the producer).However, describe here the possibility of hazardous reactions occurring under certainconditions of storage, handling and use and also if released into the environment.

Conditions to avoid

• List or describe briefly those conditions such as temperature, pressure, light,shock, etc., which may cause a dangerous reaction or harmful effect on theenvironment. These properties are related to the physical and chemical properties.

• Describe other potential dangers such as dust explosions and contamination withorganic substances resulting in an increased risk of explosion and/or fire.

Materials to avoid

• List materials such as combustible materials, farm chemicals, acids, bases,oxidising agents or any other specific substances, which may cause a dangerousreaction and if possible give a brief description.

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Hazardous decomposition products

• Give a list of the likely hazardous materials produced in dangerous amounts upondecomposition e.g. NOx gases, ammonia etc. Decomposition due to fire shouldalready be given in section 5.

Section 11: Toxicological information

Describe the various toxicological (health) effects, which can arise on coming intocontact with the substance or preparation. These should include:

• Dangerous-to-health effects from exposure to the substance or preparation, basedon, for example, test data and experience.

• Where appropriate, delayed, immediate and chronic effects from short- and long-term exposure.

Give information, when available, on the following groups of potential effects for theclassified and other hazardous ingredients given in section 3, or the preparation:

• Toxicokinetics, metabolism and distribution, this should be addressed if relevantinformation is available, see OECD Guidelines 417 for further information.

• Acute effects (acute toxicity, irritation and corrosivity) e.g. adverse effects arisingfrom the different routes of exposure (inhalation, ingestion, skin and eye contact)that may already be given in section 2.

• Sensitisation

• Chronic toxicity: long term effects such as irritation.

• CMR effects (Carcinogenity, Mutagenicity and Reproductive toxicity). All therelevant toxicity endpoints should be included and a statement on the CMRcategory 1 or 2 status of the substance or preparation.

For a number of substances, toxicological data are available from differentsources. The data included in the model SDSs have been complied fromproprietary data owned by EFMA/TFI. Under REACH the above data shouldbecome available from the IUCLID 5 database.

• Remarks

Add any other relevant information.

Section 12: Ecological information

Describe the most important characteristics, behaviour and environmental fate of thesubstance or ingredients of the preparation in air, water and/or soil. Where available,give relevant test data (e.g. LC50 fish ≤ 1 mg/l). For example, if the product is notexpected to have an adverse environmental impact this can be stated or if it is likely tohave an impact the nature of the impact should be given (e.g. excess nitrates can causeeutrophication).

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Ensure that information relevant to the environment is provided under other sectionsof the SDS, especially advice for controlled release, accidental release measures,transport and disposal considerations under sections 6, 7, 13, 14 and 15.

The following issues should be addressed as relevant and where data is available. Datais expected to be available from the IUCLID 5 database.

Ecotoxicity

• List any relevant available data on aquatic toxicity, both acute and chronic forfish, crustaceans, algae and other aquatic plants (e.g. LC50, EC50, and IC50).

• Where the substance or preparation has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants shall be mentioned.

Mobility

• Describe the potential of the substance or the appropriate constituents of apreparation, if released to the environment, to be transported to groundwater or farfrom the site of release.

• Relevant data might include:

•• Known or predicted distribution to environmental compartments,

•• Surface tension,

•• Absorption/desorption.

•• Refer to the physicochemical properties given in section 9.

Persistence and degradability

• Describe the potential of the substance or the appropriate constituents of apreparation to degrade in relevant environmental media, either throughbiodegradation or other processes such as oxidation, hydrolysis or photolysis. (Itshould be noted that some biodegradation tests may not be applicable forinorganic substances).

• Degradation half lives shall be quoted where available (Aquatic half-life).

• The potential of the substance or appropriate constituents of a preparation todegrade in sewage treatment plants shall also be mentioned.

Bioaccumulative potential

• If known, describe the potential of the substance or the appropriate constituents ofa preparation to accumulate in biota and eventually to pass through the food chain,with reference to the octanol-water partition coefficient (Kow or LogPow) andbioconcentration factor (BCF).

Results of PBT assessment

• This assessment forms part of a CSR. Further guidance is given in Annex 13 ofthe REACH Regulation.

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Other adverse effects

• Other information, if available, should be included for any other adverse effectson the environment, e.g. ozone depletion potential, photochemical ozone creationpotential, endocrine disrupting potential and/or global warming potential.

Section 13: Disposal considerations

Methods of disposal and Package waste disposal

• Specify the appropriate methods of disposal of the substance/preparation and anycontaminated packaging e.g., recycling, land filling, incineration etc.

• If the disposal of the substance or preparation (surplus or waste resulting from theforeseeable use) presents a danger, give a description of these residues andinformation on their safe handling. E.g. do not empty into drains or other watercourses.

Note: Refer to any relevant Community provisions relating to waste. In their absence,it is useful to remind the user that national or regional provisions may be in force.

Section 14: Transport information

Specify any special precautions that a user needs to be aware of or needs to comply within connection with transport or conveyance either within or outside his premises(nationally and internationally).

If a product is not subject to transport regulation this should be stated on the SDS.e.g. not classified as hazardous according to the relevant transport regulation (ADR,RID etc).

Provide information on the transport classification for each of the modal regulationsfor substances and/or preparations, where relevant:

ADR (road, Council Directive 94/55/EC (9))/RID (rail, Council Directive 96/49/EC(10), ADN/ADNR (inland waterways), IMDG (sea) and ICAO/IATA (air).

This might include:

• UN number

• Proper shipping name

• Class

• Packing group

• Label

• Other applicable information (e.g., hazard identification number, Emergencyschedules), marine pollutant, tunnel code).

Reference should be made to specific national transport regulations, if any (e.g. inthe UK, The Carriage of Dangerous Goods and Use of Transportable PressureEquipment Regulations 2007, SI No. 1573, 2007).

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Section 15: Regulatory information

• Give the health, safety and environmental information shown on the labelaccording to Directives 67/548/EEC, 1999/45/EC and their amendments (arisingfrom the classification of the substance or preparation):

– The relevant Hazard symbol(s)

– The appropriate R and S phrases written in full text

• Other Regulations: Other relevant information arising from the above Directivescan be included. For example, mention the Community law and the national lawsthat implement these provisions and any other national measures that may berelevant e.g. Seveso Directive, REACH, Regulation (EC) 1907/2006, Restrictionon Marketing and Use (76/769/EC), EU Fertilizer Regulation 2003/2003/EC etc.

Section 16: Other information

• Indicate any other information that the supplier assesses as being of importancefor the health and safety of the user and for the protection of the environment, forexample:

•• Recommended restrictions on use (i.e. non-statutory recommendations bysupplier),

•• Further information (written references and/or technical contact point),

•• Sources of key data used to compile the data sheet.

• List of relevant Risk phrases. Write out the full text of any R phrases referred tounder sections 2 and 3 above of the SDS.

• List relevant Symbols

• Training advice: if applicable give some guidance here.

• Date of the previous SDS

• Modifications in this version: For a revised SDS, indicate clearly the information,which has been added, deleted or revised (unless this has been indicatedelsewhere e.g. text which has been modified since the previous version is markedwith an asterisk).

• References: Main sources of data used in the SDS.

Disclaimer

It is usual to have a disclaimer clause at the end of the SDS e.g.

The information in this Safety Data Sheet is given in good faith and belief in itsaccuracy based on our knowledge of the substance/preparation concerned at the date ofpublication. It does not imply the acceptance of any legal liability or responsibilitywhatsoever by <the Company> for the consequences of its use or misuse in anyparticular circumstances.

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6. REFERENCES 1) Guidance for the Compilation of Safety Data Sheets for Fertilizer Materials,

published by EFMA, 1996.

2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws,regulations and administrative provisions relating to the classification, packagingand labelling of dangerous substances. Official Journal of the EuropeanCommunities 196, 16.8.1967, p 1 (and amendments). (The most relevantconsolidated version of Directive 67/548/EEC is Directive 92/32/EC).

3) Directive 1999/45/EC of the European Parliament and of the Council of 31 May1999 concerning the approximation of the laws, regulations and administrativeprovisions of the Member States relating to the classification, packaging andlabelling of dangerous preparations.

4) Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of18 December 2006 concerning the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH), establishing a European Chemicals Agency,amending Directive 1999/45/EC and repealing Council Regulation (EEC) No793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive76/769/EEC and Commission Directives 91/155/EEC.

5) European Chemicals Agency, Guidance on Information Requirements andChemical Safety Assessment, Internet web site, http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm.

6) Globally Harmonized System of Classification and Labelling of Chemicals (GHS),2005, published by UN, ISBN 92-1-116927-5.

7) Proposal for a Regulation of the European Parliament and of the Council onclassification, labelling and packaging of substances and mixtures, and amendingDirective 67/548/EEC and Regulation (EC) No 1907/2006, 2007/0121 (COD).

8) Guidance for the Storage, Handling and Transportation of Solid MineralFertilizers, published by EFMA (2007).

9) Guidance for Safe Handling and Use of Non-conforming Fertilizers and RelatedMaterials for Producers, published by EFMA (2003).

10) Guidance for Safe Handling and Utilization of Non-conforming Solid Fertilizersand Related Materials for Fertilizer Importers, Distributors and Merchants,published by EFMA (2004).

11) Guidance for Compatibility of Fertilizer Blending Materials, published by EFMA(2006).

12) Guidance for the Storage of Hot Ammonium Nitrate Solutions, published byEFMA (2005).

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13) Guidance for Sea Transport of Ammonium Nitrate Based Fertilizers, published byEFMA (2004).

14) Guidance for Inspection of Atmospheric, Refrigerated Ammonia Storage Tanks,2nd Edition, published by EFMA (2008).

15) Guidance for Transporting Ammonia by Rail, 2nd edition, published by EFMA(2007).

16) Hazardous Properties of Ammonia, published by EFMA & IFA (1990).

17) Set of eight Best Available Techniques (BAT) booklets, published by EFMA(2000).

18) Council Directive of 21 December 1989 on the approximation of the laws of theMember States relating to personal protective equipment (89/686/EEC).

19) Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methodspursuant to Regulation (EC) No 1907/2006 on the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH).

20) Recommendations on the Transport of Dangerous Goods, Manual of Tests andCriteria, 4th Edition, United Nations, New York, 2003.

21) Fertilizers – Determination of bulk density (loose), CEN standard EN 1236 (1995).

22) Fertilizers – Determination of bulk density (tapped), CEN standard EN 1237(1995).

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7. ABBREVIATIONSADR European Agreement concerning the International Carriage of Dangerous

Goods by Road (in French: Accord européen relatif au transportinternational des marchandises Dangereuses par Route)

AN Ammonium Nitrate

BC Bulk Cargo

BCF Bioconcentration factor

CAN Calcium Ammonium Nitrate

CAS Chemical Abstracts Service

CEN Comité Européen de Normalisation (European Committee forStandardisation)

CLP Classification, Labelling and Packaging

CMR Carcinogenity, mutagenicity and toxicity for reproduction

CSA Chemical Safety Assessment

CSR Chemical Safety Report

DAP Di-Ammonium Phosphate

DNEL Derived No Effect Level

d50 Mean particle size

DU Downstreams Users

EC European Community

EC50 Effective Concentration (Median) for 50% of the response under test

EEC European Economic Community

EFMA European Fertilizer Manufacturers’ Association

EINECS European Inventory of Existing Chemical Substances

ELINCS European List of Notified Chemical Substances

ES Exposure Scenario

GHS Globally Harmonized System of Classification and Labelling ofChemicals

IATA International Air Transport Association

ICAO International Civil Aviation Organisation

IC50 Concentration of a drug that is required for 50% inhibition in vitro

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IMDG International Maritime Dangerous Goods (Code)

IMSBC International Maritime Solid Bulk Cargoes

IUCLID International Uniform Chemical Information Database

Kow Octanol-water partition coefficient

LC50 Lethal Concentration (Median) for 50% of the population under test

LD50 Lethal Dose for 50% the population under test

NOx Oxides of Nitrogen

NPK Compound Fertilizer containing the nutrients Nitrogen, Phosphorus andPotassium

OECD Organisation for Economic Cooperation & Development

OEL Occupational Exposure Limit

OJ Official Journal (of the European Community)

PBT Persistent Bioaccumulable and Toxic

PNEC Predicted No Effect Concentration

PPE Personal Protection Equipment

PVC Poly Vinyl Chloride

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

RID Regulations Concerning the International Carriage of Dangerous Goodsby Rail (in French: Règlement concernant le transport Internationalferroviaire des marchandises Dangereuses)

R phrase Risk phrase

SCOEL (European) Scientific Committee for Occupational Exposure Limits

SDS Safety Data Sheet

S phrase Safety phrase

TFI The Fertilizer Institute

UN United Nations

UNECE United Nations Economic Commission for Europe

WEEL Workplace Environmental Exposure Limit

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27

APPENDICESAPPENDIX 1 Provisional List of substances and preparations of model

Safety Data Sheets 28

APPENDIX 2 Model EFMA Safety Data Sheet Format 29

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28

APPENDIX 1: PROVISIONAL LIST OF SUBSTANCES ANDPREPARATIONS OF MODEL SAFETY DATASHEETS

Ammonia anhydrous

Ammonia solution

Ammonium nitrate fertilizer

Ammonium nitrate solution

Ammonium nitrate sulphate

Ammonium sulphate

Calcium Ammonium Nitrate (CAN)

Di-ammonium phosphate

Magnesium nitrate

Mono- ammonium phosphate

Nitric acid

Nitric acid, ammonium calcium salt also called Calcium nitrate double salt

NPK: AN-based

NPK: Urea-based

Phosphoric acid

Potassium nitrate

Potassium sulphate

Sodium nitrate

Single superphosphate (SSP)

Triple superphosphate (TSP)

Urea

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Version

Issue date

1 Identification of the substance/preparation and of the company/undertaking

2

3

CAS no. EC no. % (w/w)

CAS no. EC no. % (w/w)

4

Conforms to 1907/2006/EC

Safety Data Sheet

Hazardous ingredients

Other ingredients

Chemical name

Chemical name

EU index number (Annex 1)

Use of the substance/preparation

Company e-mail for SDS

Emergency telephone

First aid measures

Composition/information on ingredients

Hazards identification

Skin contact

Environmental hazards

Health hazards

Classification

Physical and chemical hazards

Note to physician

Eye contact

Other

General

Ingestion

Inhalation

EC no. means EINECS or ELINCS number.

Classification

Synonyms

Chemical formula

CAS No.

EC No

Company name

Company address

Company telephone

Product name

Commercial product name

Common chemical name

REACH or National Product Registration No.

Firm logo

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APPENDIX 2: MODEL EFMA SAFETY DATA SHEET FORMAT

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30

5

6

7

8

9

Relative density

Density

Loose bulk density

Vapour pressure at 20°C

Decomposition temperature

Minimum ignition energy

Oxidising properties

Critical temperature

Flash point

Flammability

Explosive properties

Auto-ignition temperature

Respiratory system

Skin and body

Hands

Eyes

Engineering measures

Hygienic measures

Exposure controls / Personal protection

Personal protection

Packaging materials

Note: See section 10 for stability and reactivity

Exposure limit values

Specific use(s)

Suitable extinguishing media

Extinguishing media not to be used

Handling

Storage

Fire-fighting measures

pH

Boiling point or range

Melting point or range

Accidental release measures

Physical and chemical properties

Appearance

Odour

Environmental exposure controls

Advice on personal protection is applicable for high exposure levels.

Select proper personal protection based on a risk

Specific hazards

Hazardous thermal decomposition and combustion products

Note: see section 8 for personal protective equipment and section 13 for waste disposal.

Handling and storage

Special fire fighting procedures

Special protective equipment for fire-fighters

Personal precautions

Environmental precautions

Methods for cleaning up

Remarks

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10

11

Test Species Route Result

12

Test Species Period Result

Aquatic half-life Photolysis Biodegradability

Kow or LogPow Bioconcentration factor

Ingredient namePersistence and degradability

Ecological information

Ecotoxicity

Mobility

Reproductive toxicity

Remarks

Ingredient name

Bioaccumulative potential Ingredient name

Stability

Results of PBT assessment

Acute effects

Sensitisation

Chronic toxicity

Stability and reactivity

Toxicological information

Ingredient name

Carcinogenicity

Mutagenicity

Water solubility

Miscibility

Fat solubility

Conductivity

Gas group

Remarks

Vapour density

Evaporation rate

Partition coefficient (n-octanol/water)

Viscosity

Conditions to avoid

Mean particle size

Other adverse effects

Toxicokinetics, metabolism and distribution

Materials to avoid

Hazardous decomposition products

In case of fire: see section 5.

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13

14

UN Number Proper shipping name

Class Packing group Label

ADR/RID

ADN/ADNR

IMDG

ICAO/IATA

15

16

Training advice

Date of the previous SDS

References

Modifications in this version

Other information

Risk phrases

Symbols

Regulatory information

Hazard symbol

R and S phrases

Other regulations

Other applicable information

Disposal considerations

Methods of disposal

Package waste disposal

Note: see section 7 for safe handling and storage

Disclaimer

The information refers to sections 2 and 3

Transport information

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Avenue E. van Nieuwenhuyse, 6B-1160 BrusselsBelgiumTel: +32 2 675 35 50Fax: +32 2 675 39 61E-mail: main@efma.be

For more information about EFMAvisit the web-site www.efma.org

e u r o p e a n f e r t i l i z e r m a n u f a c t u r e r s a s s o c i a t i o n

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